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FDA 510(k)

ULTIMATE COMPRESSION SCREW SYSTEM

K-Number: K972722 · 1998-01-23

ApplicantOrthopedic Designs, Inc.
Decision Date1998-01-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ULTIMATE COMPRESSION SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Designs, Inc.. It received FDA 510(k) clearance on 1998-01-23 under 510(k) number K972722. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ULTIMATE COMPRESSION SCREW SYSTEM?

ULTIMATE COMPRESSION SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1998-01-23. The listed applicant is Orthopedic Designs, Inc.. The 510(k) number is K972722.

When did ULTIMATE COMPRESSION SCREW SYSTEM receive FDA 510(k) clearance?

ULTIMATE COMPRESSION SCREW SYSTEM received FDA 510(k) clearance on 1998-01-23, under 510(k) number K972722.

Who is the listed applicant for ULTIMATE COMPRESSION SCREW SYSTEM?

The FDA 510(k) record lists Orthopedic Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTIMATE COMPRESSION SCREW SYSTEM?

The FDA product code for ULTIMATE COMPRESSION SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Orthopedic Designs, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K030619ODI 7.0MM CANNULATED SCREW SYSTEMK014189ODI TALON INTRAMEDULLARY HIP NAILK984331ODI ULTIMATE COMPRESSION HIP SCREW

Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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